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J Autoimmun. 2021 Dec; 125: 102745.
Published online 2021 Nov 11. doi: 10.1016/j.jaut.2021.102745
PMCID: PMC8580815
PMID: 34781161


AUTOIMMUNE HEPATITIS AFTER SARS-COV-2 VACCINE: NEW-ONSET OR FLARE-UP?

Enver Avcia,∗ and Fatma Abasiyanikb


ENVER AVCI

aDepartment of Gastroenterology, KTO Karatay University Medical School
Affiliated Konya Medicana Hospital, Konya, Turkey

Find articles by Enver Avci


FATMA ABASIYANIK

bDepartment of Pathology, Private Konya Medical Pathology Laboratory, Konya,
Turkey

Find articles by Fatma Abasiyanik
Author information Article notes Copyright and License information Disclaimer
aDepartment of Gastroenterology, KTO Karatay University Medical School
Affiliated Konya Medicana Hospital, Konya, Turkey
bDepartment of Pathology, Private Konya Medical Pathology Laboratory, Konya,
Turkey
∗Corresponding author. Department of Gastroenterology, KTO Karatay University
Medical School affilated Medicana Hospital, 42000, Konya, Turkey.
Received 2021 Oct 11; Revised 2021 Nov 4; Accepted 2021 Nov 7.
Copyright © 2021 Published by Elsevier Ltd.
Since January 2020 Elsevier has created a COVID-19 resource centre with free
information in English and Mandarin on the novel coronavirus COVID-19. The
COVID-19 resource centre is hosted on Elsevier Connect, the company's public
news and information website. Elsevier hereby grants permission to make all its
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including this research content - immediately available in PubMed Central and
other publicly funded repositories, such as the WHO COVID database with rights
for unrestricted research re-use and analyses in any form or by any means with
acknowledgement of the original source. These permissions are granted for free
by Elsevier for as long as the COVID-19 resource centre remains active.
This article has been cited by other articles in PMC.



ASSOCIATED DATA

Data Availability Statement

Data will be made available on request.

Go to:


ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been
reported to trigger several autoimmune diseases. There are also recent reports
of autoimmune diseases that develop after SARS-CoV-2 vaccines. Autoimmune
hepatitis is a polygenic multifactorial disease, which is diagnosed using a
scoring system.

A 61-year-old woman presented with malaise, fatigue, loss of appetite, nausea
and yellow eyes. She had a Pfizer/BioNTech BNT162b2 mRNA vaccine a month ago.
Her physical examination revealed jaundice all over the body, especially in the
sclera. The laboratory tests showed elevated liver enzymes and bilirubin levels.
Antinuclear antibody and anti-smooth muscle antibody were positive and
immunoglobulin G was markedly elevated. The liver biopsy revealed
histopathological findings consistent with autoimmune hepatitis (AIH). The
patient was diagnosed with AIH and initiated on steroid therapy. She rapidly
responded to steroid therapy.

A few cases of AIH have been reported after the COVID-19 vaccine so far.
Although the exact cause of autoimmune reactions is unknown, an abnormal immune
response and bystander activation induced by molecular mimicry is considered a
potential mechanism, especially in susceptible individuals. As intensive
vaccination against SARS-CoV-2 continues, we would like to emphasize that
clinicians should be cautious and consider AIH in patients presenting with
similar signs and symptoms.

Keywords: COVID-19, SARS-CoV-2 mRNA vaccine, Autoimmune hepatitis
Go to:


1. INTRODUCTION AND OBJECTIVE

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in
late 2019 and has rapidly spread all over the world, has infected many people
and caused millions of deaths worldwide. During this period, our knowledge of
SARS-CoV-2 infection has increased day by day and the disease has been found to
trigger many autoimmune diseases [1]. Although the exact mechanism by which
autoimmune pathologies develop is unknown, one possible mechanism is believed to
be the cross-reaction of the immune response developing after SARS-CoV-2
infection with human proteins resembling virus peptide sequences [2].

Vaccine studies were in full swing during this period and vaccines were produced
in a short period of time that can be considered a record and granted an
emergency use authorization [3]. The safety of vaccines is still a matter of
debate, and vaccine-related complications are usually local, with rare reported
cases of anaphylaxis [4].

Autoimmune hepatitis (AIH) is a multifactorial polygenic disorder that requires
the interaction of hereditary, epigenetic, immunological, and environmental
factors. Specific environmental factors, such as viral infections, may act as
environmental triggers for loss of self-tolerance to autoantigens in individuals
genetically susceptible to AIH [5,6].

We aimed to present our case of AIH developed following the Pfizer/BioNTech
BNT162b2 mRNA vaccine in the light of the literature.

Go to:


2. CASE REPORT

A 61-year-old woman with no previous complaints presented to our clinic with
malaise, fatigue, anorexia, nausea, and yellow eyes persisting for 2 weeks. She
had a history of Hashimoto's thyroiditis and hypertension and was on valsartan
160 mg/day and levothyroxine 100 mg/day for 10 years. Eight months ago, she had
COVID-19 with mild symptoms. She had no known history of liver disease and did
not use any hepatotoxic drug/agent, herbal remedies or alcohol. Her medical
history revealed that she had a Pfizer/BioNTech BNT162b2 mRNA vaccine about a
month ago. The patient's previous examinations in the national e-pulse system
showed normal hepatic laboratory values.

On physical examination, she had jaundice throughout the body, especially in the
sclera. The abdominal examination showed no defense or tenderness, with
non-palpable liver and spleen. Other physical examination findings were normal.

In laboratory tests, the complete blood count results were as follows:
leukocyte, 8530/mm³; hemoglobin, 13.3 g/dl; platelet, 199,000/mm³. The
biochemistry results were as follows: alanine aminotransferase (ALT), 455 IU/ml
(upper limit of normal (ULN) 55 IU/ml); aspartate aminotransferase (AST), 913
IU/ml (ULN 34 IU/ml); gamma glutamyl transferase (GGT), 292 IU/ml (ULN 36
IU/ml); alkaline phosphatase (ALP), 436 IU/ml (normal range: 40–150 IU/ml);
total bilirubin, 11.8 mg/dl (ULN 1,2 mg/dl); direct bilirubin, 9.18 mg/dl (ULN
0,5 mg/dl). The microbiology laboratory results were negative for hepatitis A,
B, C, Ebstein-Barr virus and cytomegalovirus serology. Ceruloplasmin and serum
copper levels were within the normal range. The result of the autoantibody study
with immunofluorescence assay was positive for antinuclear antibody (ANA) 1/100
(<1/100 negative) and anti-smooth muscle antibody (ASMA) 1/100 (<1/100
negative). On microscopic examination, ANA was weakly granular and ASMA was
positive. The immunoglobulin G was 4260 mg/dl (normal range: 552–1631 mg/dl).

The patient's ultrasound examination showed a normal liver size, with a
homogeneous parenchymal echo pattern. The gallbladder was filled with many
millimetric stones. The intrahepatic biliary tract and common bile duct were
normal. The longitudinal axis of the spleen was 130 mm. No thrombus was present
in the splenic vein and portal vein. The magnetic resonance
cholangiopancreatography (MRCPI) showed that the bile ducts were of normal
diameter, with no stone or sludge. The abdominal computed tomography (CT) showed
no space-occupying formation.

A percutaneous liver biopsy was performed, considering that the patient might
have autoimmune hepatitis (AIH). The histopathological examination showed narrow
sinusoids and lymphocyte infiltration, severe portal and periportal lymphocyte
infiltration, periseptal interface hepatitis, 4–5 spotty necrosis in each high
magnification field of view, and limiting plate disorder, but no confluent
necrosis. There was mild fibrosis with Masson's trichrome staining. The
patient's Ishak histological activity index was 10/18 and fibrosis score was
stage 2/6 (Fig. 1 ).

Open in a separate window
Fig. 1

Transaminases (a) and bilirubin (b) after steroid therapy.

The simplified autoimmune hepatitis score was found to be 7. The patient was
diagnosed with AIH and initiated on oral prednisolone 40 mg. After 14 days,
azathioprine (AZA) was added to the treatment and the steroid dose was
incrementally reduced. The dose of prednisolone was reduced by 5 mg weekly,
while the dose of AZA was increased to 100 mg. On the 35th day of the treatment,
the patient did not have any complaints, with resolved icterus. Her laboratory
results were insignificant other than mildly elevated transaminase and bilirubin
levels (Fig. 2 ). She is currently receiving prednisolone 20 mg and AZA 100 mg.

Open in a separate window
Fig. 2

Histological findings of the case who developed autoimmune hepatitis after
SARS-CoV-2 vaccine. a) Medium magnification image(x40, hematoxylin-eosin)
showing limiting plate disruption, severe periportal inflammation and fibrous
tissue increase. b) High magnification(x100, hematoxylin-eosin) showing spotify
necroses, intense inflammation, severe deteriotion of the limiting plate.

Go to:


3. DISCUSSION

In this report, we presented a case of AIH developed following the
BioNTech-Pfizer mRNA vaccine and resolved by steroid treatment. Although
virus-induced AIH has been well described in the literature, post-vaccination
AIH is extremely rare [7]. Until now, few cases of AIH has been reported after
COVID-19 vaccination in the literature [[8], [9], [10], [11], [12], [13], [14],
[15], [16], [17]], (Table 1 ).


TABLE 1

Characteristics of patients with autoimmune hepatitis after SARS-CoV-2 vaccine.

StudyVaccineGenderAgeAutoimmune disease historyAntibodiesIgGBiopsySteroid
responseBril et alPfizer-BioNTechFemale35NoneANA
Anti-dsDNANormalCompatibleYesLondono et alModernaFemale41NoneANA
SMA
SLA
LC-1HighCompatibleYesClayton-Chubb et
al.Oxford-AstraZenecaMale36NoneANANormalCompatibleYesTan et al.ModernaFemale56NoneANA
SMAHighCompatibleYesMcShane et
al.ModernaFemale71NoneSMAHighCompatibleYesLodato et
al.Pfizer-BioNTechFemale43NonenegativeNormalCompatibleYesRocco et
alPfizer-BioNTechFemale80Hashimoto diseaseANAHighCompatibleYesRela et al (two
cases)CovishieldFemale38NoneANAHighCompatibleYesMale65None––CompatibleYesVuille-Lessard
E et al
Ghielmetti M et alModerna
ModernaFemale
Male76
63Hashimoto disease
NoneANA
ASMA anti-aktin
ANCA
ANAHigh
HighCompatible
CompatibleYes
Yes

Open in a separate window

IgG, ımmunglobulin G; ANA, anti nuklear antikor; SMA, smooth muscle antibodies;
dsDNA, double stranded DNA antibodies; LC1, liver sitozol antibody; anti-SLA,
soluble liver antijen antibodies; ANCA, anti neutrophil cytoplasmic antibodies.

Although the exact mechanism of post-vaccination autoimmune diseases is unknown,
possible mechanisms have been reported as follows: (1) An abnormal immune
response induced by molecular mimicry, especially in susceptible individuals
[18]; (2) Bystander activation through which microbial agents release
sequestered self-antigens from host tissue that activate antigen-presenting
cells and dormant autoreactive T-helper cells [19].

Autoimmune hepatitis is an immune-mediated chronic inflammatory disease with no
specific diagnostic markers. The diagnosis is based on clinical and laboratory
findings, histological abnormalities, increased serum IgG value, and the
presence of one or more autoantibodies [20]. A scoring system is used for
diagnosis, and the simplified scoring system provides the most accurate results
for typical cases [21]. In our case, we used the simplified scoring system based
on typical findings.

The first case of AIH after SARS-CoV-2 vaccination in the literature was
presented by Bril F et al. [8]. The patient was a 35-year-old woman who had
given birth 3 months ago. She presented with jaundice shortly after the mRNA
vaccine. Unlike our case, she had no known autoimmune disease, and
autoantibodies other than ANA were negative and IgG was normal. Afterward, the
number of cases shared in the literature has increased (Table 1). Of note, most
of the patients were female. The case presented by Lessard et al. was quite
similar to our case. A 76-year-old patient developed AIH after the mRNA vaccine
[15]. The patient had a history of Hashimoto's disease, as in our case.
Autoantibodies were positive and IgG level was high. The patient had typical
findings on biopsy and responded well to steroids.

Although it is not certain whether AIH was triggered by SARS-CoV-2 vaccine in
our case, the absence of a history of hepatotoxic drug/agent use for liver
disease, negative viral serology, a history of Hashimoto's disease,
biochemical/histopathological findings consistent with AIH, simplified AIH
score, and good response to immunosuppressive treatment suggest that this
relationship is not a coincidence. However, in our case, a fibrosis score of 2
raises the question of underlying silent autoimmune hepatitis. The patient's
past records from the national registry system showed no pathological findings.
In the literature, 25–34% of autoimmune hepatitis patients are asymptomatic,
with spontaneous laboratory improvement in approximately 12% of symptomatic
patients [22,23]. Therefore, we could not rule out the presence of an underlying
silent autoimmune hepatitis in our case.

In conclusion, while intensive vaccination against SARS-CoV-2 continues, the
diagnosis of AIH secondary to mRNA vaccines should be included in the
differential diagnosis in cases of acute hepatitis of unexplained etiology.

Go to:


DATA AVAILABILITY

Data will be made available on request.

Go to:


REFERENCES

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 * Abstract
 * 1. Introduction and objective
 * 2. Case report
 * 3. Discussion
 * Data availability
 * References

1. Liu Y., Sawalha A.H., Lu Q. COVID-19 and autoimmune diseases. Curr. Opin.
Rheumatol. 2021;33(2):155–162. doi: 10.1097/BOR.0000000000000776. Mar 1. [PMC
free article] [PubMed] [CrossRef] [Google Scholar] [Ref list]
2. Oldstone M.B. Molecular mimicry: its evolution from concept to mechanism as a
cause of autoimmune diseases. Monoclon. Antibodies Immunodiagn. Immunother.
2014;33(3):158–165. doi: 10.1089/mab.2013.0090. [PMC free article] [PubMed]
[CrossRef] [Google Scholar] [Ref list]
3. E Oliver S., Gargano J.W., Marin M., Wallace M., Curran K.G., Chamberland M.,
et al. The advisory committeeon immunization practices' interim recommendation
for use of Pfizer-BioNTech COVID-19 vaccine: United States, December 2020. MMWR
Morb. Mortal. Wkly. Rep. 2020;69(50):1922–1924. [PMC free article] [PubMed]
[Google Scholar] [Ref list]
4. Allergic reactions including anaphylaxis After receipt of the first dose of
pfizer-BioNTech COVID-19 vaccine - United States, December 14-23, 2020. MMWR
Morb. Mortal. Wkly. Rep. 2021;70:46–51. doi: 10.15585/mmwr.mm7002e1. [PMC free
article] [PubMed] [CrossRef] [Google Scholar] [Ref list]
5. Christen U., Hintermann E. Pathogen infection as a possible cause for
autoimmune hepatitis. Int. Rev. Immunol. 2014;33:296–313.
doi: 10.3109/08830185.2014.921162. [PubMed] [CrossRef] [Google Scholar] [Ref
list]
6. Floreani A., Leung P.S., Gershwin M.E. Environmental basis of autoimmunity.
Clin. Rev. Allergy Immunol. 2016;50:287–300. doi: 10.1007/s12016-015-8493-8.
[PubMed] [CrossRef] [Google Scholar] [Ref list]
7. Perumalswami P., Peng L., Odin J.A. Vaccination as a triggering event for
autoimmune hepatitis. Semin. Liver Dis. 2009;29:331–334.
doi: 10.1055/s-0029-1233537. [PubMed] [CrossRef] [Google Scholar] [Ref list]
8. Bril F., Al Diffalha S., Dean M., Fettig D.M. Autoimmune hepatitis developing
after coronavirus disease 2019 (COVID-19) vaccine: causality or casualty? J.
Hepatol. 2021:222–224. doi: 10.1016/j.jhep.2021.04.003. [PMC free article]
[PubMed] [CrossRef] [Google Scholar] [Ref list]
9. Tan C.K., Wong Y.J., Wan L.M., Ang T.L., Kumar R. Autoimmune hepatitis
following COVID-19 vaccination: true causality or mere association? J. Hepatol.
2021 doi: 10.1016/j.jhep.2021.06.009. [PMC free article] [PubMed] [CrossRef]
[Google Scholar] [Ref list]
10. Mcshane C., Kiat C., Rigby J., Crosbie O. The mRNA Covid-19 vaccine-A rare
trigger of autoimmune hepatitis? J. Hepatol. 2021
doi: 10.1016/j.hep.2021.06.044. [PMC free article] [PubMed] [CrossRef] [Google
Scholar] [Ref list]
11. Londono M.C., Gratacos-Gines J., Saez-Penataro J. Another case of autoimmune
hepatitis after SARS-CoV-2 vaccination.Still casualty? J. Hepatol. 2021
doi: 10.1016/j.jhep.2021.06.004. [PMC free article] [PubMed] [CrossRef] [Google
Scholar] [Ref list]
12. Clayton-Chubb D., Schneider D., Freeman E., Kemp W., Roberts S.K. Comment to
the letter of Bril F et al. “Autoimmune hepatitis developing after coronavirus
disease 2019 (COVID-19) vaccine: causality or casualty?” J. Hepatol. 2021
doi: 10.1016/j.jhep.2021.06.014. [CrossRef] [Google Scholar] [Ref list]
13. Lodato F., Larocca A., D'Errico A., Cennamo V. An anusual case of acute
cholestatic hepatitis after m-RNABNT162b2 (comirnaty) SARS-COV-2 vaccine:
coincidence,autoimmunity or drug related liver injury? J. Hepatol. 2021
doi: 10.1016/j.jhep.2021.07.005. [PMC free article] [PubMed] [CrossRef] [Google
Scholar] [Ref list]
14. Rocco A., Sgamato C., Compare D., Nardone G. Autoimmune hepatitis following
SARS-CoV-2 vaccine: may not be a casuality. J. Hepatol. 2021:728–729.
doi: 10.1016/j.jhep.2021.0538. [PMC free article] [PubMed] [CrossRef] [Google
Scholar] [Ref list]
15. Lessard E.V., Montani M., Bosch J., Semmo N. Autoimmune hepatitis triggered
by SARS-CoV-2 vaccination. J. Autoimmun. 2021 doi: 10.1016/j.jaut.2021.102710.
[PMC free article] [PubMed] [CrossRef] [Google Scholar] [Ref list]
16. Rela M., Jothimani D., Vij M., Rajakumar A., Rammohan A. Auto-immune
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